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Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards

Document the reproducibility of a particle counter by permitting a continuous record of its performance.

Manufacturer:  Thermo Scientific™ CSBX

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Catalog No. 09-980-236


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Specifications

Description

Document the reproducibility of a particle counter by permitting a continuous record of its performance with Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards, ready-to-use precision standards designed for regular use in liquid particle counters for USP <788> and <789> verification. Data is documented for internal or customer audits by using a NIST™-traceable microsphere suspension with a known concentration.

Features:

  • Contains NIST™-traceable size standards with a measured particle count
  • Developed for manufacturers of parenteral drugs and ophthalmic solutions seeking interim verification of USP <788> and <789> verification (Particulate Matter in Injections and Particulate Matter in Opthalmic Solutions)
  • Particle diameters traceable to the Standard Meter through the National Institute of Standards and Technology
  • Prepared with the same exacting procedures as the USP Count Reference Standard, providing process control data for particle counting consistency and verification of size calibration
Description & Specifications

Specifications

Contains trace amount of surfactant
3800 particles/mL ± 15%
Used by manufatures of parenteral drugs and ophthalmic solutions who are seeking interim verification of USP <788> and <789>.
15.0 ± 0.2µm
Polystyrene
20 x 25mL bottles
<3%
Unless otherwise stated, refrigerate 2° to 8deg;C product when not in use but do not freeze. Store upright and keep bottle tightly sealed. Mix product with gentle inversion by hand or vortex mixer.
USP Verification
Polystyrene
Polystyrene microspheres in water
15.0μm ± 0.2μm
Certificate of Calibration and Traceability to NIST
1.05g/cm3
1.59 at 589nm (25°C)
Product stable for a minimum of 12 months
Count Control Particles
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